IP protection, page-10

Post #: 75363411

The composition of matter patent (the IP for the actual molecule assigned to Novartis Animal Health then acquired by Eli Lilly/Elanco) has expired / is expiring really soon - depends on the jurisdiction and what extensions have been granted.

This would then leave us free to pursue the commercialisation of MPL without having to engage with the owner of the molecule about licensing, royalites, etc. Our claims relate to the use of MPL in a broad range of diseases and operate to restrict others from pursuing the same applications - which is where our expansive 'mTOR pathway related diseases' patent family is hugely valuable.

Now add in ODD in the USA - which confers 7 years of marketing exclusivitiy for MPL in ALS/MND in that jurisdiction. The ODD exclusivity clock only starts ticking AFTER we gain FDA approval (assuming we do - and that could be within 18 months) and operates independently to the patent situation. No one else can then market MPL for the treatment of ALS in the USA - the FDA won't approve it.

I understand the company is also working to achieve the same status in the EU - only that comes with 10 years of exclusivity.

A really strong position to be in.

Hope this useful.

Cheers

Densy